Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis

NCT ID: NCT00693693

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-09-30

Brief Summary

The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.

Detailed Description

An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.

The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.

Adherence will be measured by MEMs cap.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cream-

topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis

Group Type: ACTIVE_COMPARATOR

hydrocortisone 17-butyrate 0.1% Cream preparation

Intervention Type: DRUG

Apply medication twice a day to affected areas of atopic dermatitis

Ointment

topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis

Group Type: ACTIVE_COMPARATOR

hydrocortisone 17-butyrate 0.1% Ointment preparation

Intervention Type: DRUG

Apply medication twice a day to affected areas of atopic dermatitis

Lipocream

topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis

Group Type: ACTIVE_COMPARATOR

hydrocortisone 17-butyrate 0.1% Lipocream preparation

Intervention Type: DRUG

Apply medication twice a day to affected areas of atopic dermatitis

Interventions

hydrocortisone 17-butyrate 0.1% Cream preparation

Apply medication twice a day to affected areas of atopic dermatitis

Intervention Type: DRUG

hydrocortisone 17-butyrate 0.1% Ointment preparation

Apply medication twice a day to affected areas of atopic dermatitis

Intervention Type: DRUG

hydrocortisone 17-butyrate 0.1% Lipocream preparation

Apply medication twice a day to affected areas of atopic dermatitis

Intervention Type: DRUG

Other Intervention Names

Locoid; locoid; locoid

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ 18 years of age.
• Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale)
• Subjects must have >5% TBSA and <30% to be enrolled.
• Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.

Exclusion Criteria

• Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the subject.
• Inability to complete all study-related visits.
• Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
• Requiring >130 gm of cream in a 2 week period.
• Having facial or groin involvement of their disease.
• Pregnant women and women who are breast feeding are to be excluded. Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00000702

Identifier Type: -

Identifier Source: org_study_id